Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease

Официальное название

Administration of Off-the-Shelf, Expanded, Most Closely HLA Matched, Third Party Adenovirus Specific T Cells for Therapy of Adenovirus Related Disease in Immunocompromised Patients

Обзор

This phase I trial studies the side effects of allogeneic adenovirus-specific cytotoxic T lymphocytes (donor T cell therapy) and to see how well they work in treating patients with a weakened immune system (immunocompromised) and adenovirus-related disease. Allogeneic adenovirus-specific cytotoxic T lymphocytes are made from donated blood cells grown in the laboratory and are designed to kill viruses that can cause infections in immunocompromised patients with adenovirus-related disease.

Подробное описание

PRIMARY OBJECTIVES:

I. To assess the feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of asymptomatic adenovirus viremia or adenovirus-related disease in immunocompromised hosts.

SECONDARY OBJECTIVES:

I. To obtain preliminary data about the efficacy of administering most closely HLA-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of adenovirus viremia or adenovirus-related disease.

II. To assess the persistence of the administered cells in the patients.

OUTLINE:

Within two weeks of enrollment, patients receive allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs) intravenously (IV) over 30 minutes. Patients may receive additional allogeneic adenovirus-specific CTL infusions at the discretion of the investigator in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 12 months.

Вмешательства

• Биопрепарат Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes
  Given IV

Первичные конечные точки

• Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0 [Срок оценки: Up to 1 year]
• Assessment of response to allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs) [Срок оценки: Up to 1 year]

Вторичные конечные точки (5)

• Overall survival (OS) [Срок оценки: From the start of study treatment up to 1 year]
• Relapse-free survival (RFS) [Срок оценки: From the start of study treatment up to 1 year]
• Cumulative incidence of adenovirus reactivation after therapy [Срок оценки: Up to 1 year]
• Cumulative incidence of graft versus host disease (GVHD) [Срок оценки: Up to 1 year]
• Reconstitution of anti-adenovirus immunity [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

• Immunocompromised patients.
• English and non-English speaking patients.
• Written informed consent and/or signed assent from patient, parent or guardian.
• Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
• Patients age 1 year or older with asymptomatic adenovirus viremia defined as no symptoms of adenovirus disease and EITHER two positive and quantifiable qPCR tests taken one week apart or one single measurement with >/= 1000 copies.
• Patients age 1 year or older with criteria of probable or definitive adenoviral diseases as defined in Appendix A.
• Willingness to comply with the study protocol requirements.

Критерии исключения

• Patients receiving prednisone > 0.1 mg/kg/day or equivalent at time of enrollment, or who have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.
• Patients with other uncontrolled infections: For bacterial infections, patients must be receiving therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
• Active acute graft versus host disease (GVHD) grade >= 2.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• M D Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT03425526 · 2017-0350 · NCI-2018-00929 · 2017-0350

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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